Human Factors / Usability Engineer
Human Factors / Usability Engineer
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Job Description
Are you a current Elekta employee
Please click here to apply through our internal career site Find Jobs - Elekta.
Want to join a team with a mission to improve and save lives
We continually look for motivated and skilled individuals who are interested in supporting our customers healthcare professionals who use our products to help patients and their communities.
We currently have the following opportunity available - please contact us for more details!
We dont just build technology. We build hope for everyone dealing with cancer.
What Youll do at Elekta
The Human Factors / Usability Engineer is responsible for providing expert guidance and required documentation regarding human factors engineering and usability testing during product development and product lifecycle to ensure the products are safe effective and user-friendly in compliance with regulations and applicable standards (such as MDR FDA IEC 62366 and ISO 14971).
Responsibilities:
- Lead and coordinate Human Factors Engineering (HFE) / Usability Engineering (UE) activities to assure regulatory compliance safe and effective solutions as well as to provide world class experiences for our customers.
- Ensure a proper integration of HFE/UE and UX/UI design principles into product design design controls and risk management activities throughout the development process and product lifecycle.
- Define usability strategies and plan conduct analyze and report user research and usability evaluations (formative and summative) to inform design decisions. Conduct root cause analysis and make improvement proposals based on evaluation results.
- Write and review technical documentation including product documentation (e.g. Usability Engineering File Risk Analysis Instructions for Use etc.).
- Perform and collaborate on use-error analysis and risk assessments residual risk evaluations ensure clear traceability to risk management files and risk control measures/mitigations and ensure that use-related hazards are identified mitigated and validated as acceptable before product release.
- Collaborate with peers and cross-functional teams (hardware/software engineers systems engineers safety engineers clinical and regulatory affairs verification & validation technical writers) to ensure proper application of HFE/UE and UX/UI design principles to products and components in which user feedback and PMS data are demonstrably used. This to ensure risk mitigation of use errors and continuous improvement of products.
- Further developing the HFE/UE discipline and process together with peers including user research and UX/UI aspects.
- Provide training to colleagues with respect to HFE/UE and UX/UI understanding fostering a culture of continuous learning and professional development.
- Keeping up to date with new developments and regulations in the field of HFE/UE (incl. UX/UI) for medical devices and inform colleagues about these.
Accountable for:
- Keeping the Usability Engineering File (UEF) up to date and ensuring that the UEF contains all necessary documentation for regulatory submissions and is properly integrated into the technical documentation/DDFs.
- Proactively contributing to the development and continuous improvement of products components and processes in the field of HFE/UE and UX/UI.
What youll bring
Education:
- Masters degree in Human Factors Cognitive Psychology Industrial Engineering Biomedical Engineering or comparable.
Experience & Knowledge:
- At least 3 years of experience in human factors / usability engineering conducting usability evaluations during product development of mechatronic devices in a regulated industry preferably medical devices.
- Strong knowledge of HFE/UE and UX/UI design principles and methodologies.
- Comprehensive knowledge of HFE/UE activities (such as performing HF/UE analyses preparing and executing formative and summative evaluations and reporting).
- Experience with Quality Management Systems electronic document control and Agile / Scrum.
- Knowledge of medical device regulations and standards (MDR FDA ISO 13485 ISO 14971 IEC 62366).
- Knowledge of clinical workflows medical imaging and/or radiation therapy and regulatory approval processes are considered a plus.
Skills & Competencies:
- Strong analytical problem solving and technical writing skills.
- Strong interpersonal and communication skills in English and preferably in Dutch as well.
- Creative accurate and results-driven. Contributing effectively towards a joint result even when the topic involved does not directly serve ones own interest.
- Proficient in analyzing complex user workflows and translating findings into actionable design inputs.
- Proficient in working with HFE/UE tools UI design data analysis and collaboration tools (e.g. Microsoft 365 Figma Jira Polarion).
- Proactive attitude; self-starting in recognizing opportunities and realizing improvements.
- Collaborate effectively across multidisciplinary teams.
- Commitment to advancing brachytherapy improving clinical outcomes accelerating product development and continuous professional development.
Why should you join Elekta
In this role you will work for a higher purpose: hope for everyone dealing with cancer and for everyone regardless of where they are in the world to have access to the best cancer care. Additionally our benefit package includes:
40 paid vacation days per year (27 vacation 13 ADV)
Global bonus plan or Profit scheme
Travel allowance
Pension fund Metalektro 50/50 payment
Insurance discounts
Active staff association
Tax benefits for fitness centers and bicycle purchases
Hybrid work option (you are required to work on location at least 3 days/week)
Hiring process
We are looking forward to hearing from you! Apply by submitting your application and rsum in English via the Apply button. Please note that we do not accept applications by e-mail.
Your Elekta contact
For questions please contact the responsible Global Talent Acquisition Partner Agata Antonijczuk at .
We are an equal opportunity employer
We evaluate qualified applicants without regard to race color religion sex sexual orientation gender identity or expression genetic information national origin disability veteran status or any other status protected by law in the locations where Elekta operates.
About Elekta
As a leader in precision radiation therapy Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve prolong and save the lives of people with cancer and brain disorders.
More than 6000 hospitals worldwide rely on Elekta technology. We openly collaborate with customers to advance sustainable outcome-driven and cost-efficient solutions to meet evolving patient needs improve lives and bring hope to everyone dealing with cancer. To us its personal and our global team of 4700 employees combine passion science and imagination to profoundly change cancer care. We dont just build technology we build hope.
Elekta is headquartered in Stockholm Sweden with presence in more than 120 markets and listed on Nasdaq Stockholm. For more information about opportunities at Elekta please visit
Employment Type
Full-Time
Key Skills
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